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Claims and Abstract availability

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English Abstract

Microneedle devices are provided for delivery of drugs across biological tissue and for controlled sampling of biological fluids in a minimally-invasive, painless, and convenient manner. The devices permit 1) drug delivery at clinically relevant rates across or into skin or other tissue barriers, and/or 2) in vivo sensing or withdrawal of biological fluids from the body, particularly from or through the skin or other tissue barriers. Drug delivery devices preferably include a plurality of hollow microneedles attached to or integrated into a substrate, and at least one reservoir (containing drug) selectably in communication with the microneedles, wherein the amount of drug to be delivered can be selectively altered. Withdrawal or sensing microneedle devices preferably include microneedles attached to or integrated into a substrate, and at least one collection chamber and/or sensor in communication with the microneedles.

Note: Claims are shown in the official language in which they were submitted.

WHAT IS CLAIMED IS:

1. A device for transport of material or energy across or into an elastic biological barrier comprising a microneedle having a tip end and a base end, a substrate connected to the base end of the microneedle, and a means for securing the biological barrier in place for insertion of the microneedle, wherein the means reduces the elasticity of the biological barrier, thereby improving penetration of the biological barrier by the microneedle.

2. The device of claim 1 wherein the biological barrier is human or other mammalian skin.

3. The device of claim 1 comprising a plurality of microneedles of varying lengths.

4. The device of claim 3 comprising four or more microneedles wherein the tip ends of the microneedles collectively define a curvilinear surface.

5. The device of claim 1 wherein the means physically manipulates the biological barrier to present a more rigid surface in the area of the biological barrier to be penetrated by the microneedle.

6. The device of claim 5 wherein the manipulation is selected from the group consisting of stretching, pulling, pinching, and a combination thereof.

7. The device of claim 6 wherein the manipulation includes pulling by reducing the atmospheric pressure over the area of the biological barrier to be penetrated by the microneedles.

8. The device of claim 7 further comprising a body portion defining a first vacuum region and a second vacuum region, wherein an array of microneedles separates the first and second regions.

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9. The device of claim 8 wherein the body portion comprises an annular ring which holds the microneedles.

10. The device of claim 9 wherein the microneedle is hollow and wherein the body portion further comprises a means for attachment to a syringe, a conduit for connection to a vacuum pump, or both.

11. The device of claim 6 wherein the means comprises a stretching cone or expandable ring around the microneedles.

12. The device of claim 1, wherein the means comprises an apparatus for vibrating the microneedle.

13. The device of claim 12, wherein the apparatus comprises a piezoelectric transducer or an electromechanical actuator.

14. A device for transport of material or energy across or into an elastic biological barrier comprising a microneedle having a tip end and a base end, a substrate connected to the base end of the microneedle, a means for securing the biological barrier in place for insertion of the microneedle, and a plurality of hollow microneedles in a linear array, wherein the substrate is mounted on a holder having one or more apertures through the holder in communication with the microneedles, thereby improving penetration of the biological barrier by the microneedle.

15. A device for transport of material or energy across or into an elastic biological barrier comprising a microneedle having a tip end and a base end, a substrate connected to the base end of the microneedle, and a means for securing the biological barrier in place for insertion of the microneedle, wherein the means for securing the biological barrier in place accelerates the tip of the microneedle into the biological barrier, accelerates the biological barrier into contact with

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the tip of the microneedle, or a combination thereof, thereby improving penetration of the biological barrier by the microneedle.

16. The device of claim 15 wherein the means for accelerating the tip of the microneedle comprises a spring or gas under compression.

17. The device of claim 14 or 6, wherein the means comprises a body portion from which a plurality of stretching elements are pivotally attached.

18. The device of claim 17 herein the stretching elements have ends provided with a nonslip feature for engagement with the biological barrier.

19. The device of claim 14 or 6, wherein the means comprises jaws for pinching a portion of the biological barrier for contact with the microneedle.

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